BD (Becton, Dickinson and Company) Document Control Specialist / Archivist in Research Triangle Park, North Carolina

Job Description SummaryThis position will function within the Quality Assurance Unit of Corporate Preclinical Development and Toxicology and will support the conduct of nonclinical laboratory investigations of medical devices and materials in accordance with GLP regulations and the BD CPDT Quality System. This position will provide control over regulated documentation by issuing and circulating required procedures, and will be the designated Archivist for GLP studies according to the requirements of 21CFR Part 58.

Job Description

Responsibilities:

1. Process Document Change Request documentation and issue documents per SOP requirements. Work with Quality Assurance to ensure that only active documents are available for use by CPDT personnel. Ensure that inactive versions are sequestered in controlled area with access limited to Document Control and QA personnel.

2. Operate the BD CPDT Document Control system for all controlled documents including but not limited to Policies, Standard Operating Procedures, Validation Protocols, and GLP study related Protocols and Reports.

3. Lead efforts to enhance CPDT Document Control system and advance the system to support Continuous Improvement efforts.

4. Routinely provide lists of documents requiring annual review to functional group leaders.

5. Act as the identified Archivist for BD CPDT GLP studies according to requirements of 21CFR Part 58 as well as other Quality System related documents. Ensure the orderly storage of retained test articles, raw data, and reports in a controlled area with limited access. Ensure expedient retrieval of archived items when requested.

6. Facilitate the transfer of documents to and from third party document scanning and storage facility. Verify the accurate transfer of data and reports to storage media.

7. Management of subcontractor accounts, including but not limited to specimen storage, scanning and archiving.

8. Take part in Quality audits of subcontracted facilities in order to ensure controlled, safe, long term storage of CPDT specimens, documentation and reports.

Position Requirements:

Typically requires a minimum of a Bachelor’s degree, preferably in a scientific discipline. A minimum of 2 years relevant experience or a combination of equivalent education and relevant experience.

Working knowledge of computers (MS Word, Excel, Access, PowerPoint, SharePoint).

#LI-OPS

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status.

Primary Work LocationUSA NC - Research Triangle Park

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Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status